Outpatient therapy for Black Fungus in nose.
Not Applicable
- Conditions
- Health Condition 1: B461- Rhinocerebral mucormycosis
- Registration Number
- CTRI/2024/05/066653
- Lead Sponsor
- All India Institute of Medical Sciences, New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patient giving written informed consent
All stable cases of invasive sinonasal mucormycosis (orbital, minimal intracranial extension included), after initial management with surgical debridement and medical therapy.
Patient with local residence/ ready for commute.
Good cognition and family support
Stable - Clinical improvement;
No major infusion reaction requiring stopping of drug administration
Adequate intake, output, blood parameters (S. K+, elctrolytes, S. creatinine, Urea) for the past 72 hours
Exclusion Criteria
Not consenting
Gross residual disease after debridement
Lack of family support and cognition
Unable to commute or do not have local residence
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy of twice weekly outpatient antimicrobial therapy (OPAT) with Liposomal Amphotericin B and its comparison with standard long term in patient anti fungal therapy for invasive sinonasal mucurmycosis at 6 weeks post therapy.Timepoint: Efficacy of twice weekly outpatient antimicrobial therapy (OPAT) with Liposomal Amphotericin B and its comparison with standard long term in patient anti fungal therapy for invasive sinonasal mucurmycosis at 6 weeks post therapy.
- Secondary Outcome Measures
Name Time Method Relationship between serum drug levels and drug toxicityTimepoint: 6 weeks <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>During Inpatient/ Outpatient therapy;Response rate of patients who become candidate for OPAT. <br/ ><br> <br/ ><br>Timepoint: trial completion.